Phase I Trial of Oral Metronomic Topotecan and Oral Pazopanib to Treat Recurrent/Persistent Gynecologic Tumors

Completed · Phase 1

Conditions studied: Gynecologic Tumors

In brief

This is a Phase 1, dose-escalation study in female patients with recurrent or persistent gynecologic tumors.

Key facts

Study ID

NCT00800345

Run by

Vector Oncology

People needed

33

Starts

2009-04-01

Expected to finish

2015-09-01

Last updated by the study team

2017-03-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must provide written informed consent prior to the performance of study specific procedures, and must be willing to comply with treatment and follow-up.
• Female patients, greater than 18 years of age with a histologically confirmed recurrent/persistent gynecologic malignancy.
• For patients with recurrent/persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma: persistent disease = progression during primary platinum therapy; recurrent disease = disease that recurs ≤ 12 months after discontinuing primary platinum therapy; if disease recurrence occurs > 12 months after discontinuing primary platinum therapy, there must be progression either during a 2nd platinum therapy or < 6 months after discontinuing the 2nd platinum therapy.
• For patients with other gynecologic malignancies:
• Malignancy is metastatic or unresectable and no curative or palliative measures exist or are no longer effective.
• Maximum of two total prior treatments (this includes neoadjuvant, adjuvant, and metastatic settings) for the recurrent or persistent gynecologic tumors including chemotherapy, hormonal therapy, investigational therapy, radiation therapy, etc.)
• Disease may be measurable or non-measurable according to RECIST version 1.0
• Gynecologic Oncology Group (GOG) performance status of 0,1,or 2
• Must have a life expectancy of at least six months
• Adequate bone marrow, liver, renal, and cardiac function at study entry as assessed by the following:
• Hemoglobin > 9.0 g/dL.
• Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L.
• Platelet count ≥ 100 x 10\^9/L.
• Prothrombin time (PT) or international normalized ratio (INR) < 1.2 x upper limit of normal (ULN).
• Partial thromboplastin time (PTT) < 1.2 x ULN.
• Total bilirubin ≤ 1.5 x ULN.
• Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x ULN.
• Creatinine ≤ 1.5 mg/dL or if serum creatinine is greater than 1.5 mg/dL, calculated creatinine clearance must be > 50 mL/min
• Urine dipstick for protein < 2+ or urine protein creatinine (UPC) ratio < 1.0.
• Left ventricular ejection fraction (LVEF) ≥ 50% or the institutional lower limit of normal (LLN)
• Patients must be physiologically incapable of becoming pregnant, be postmenopausal, or have a negative pregnancy test and agree to use adequate contraception.

You may not qualify if…

• Treatment naive patients.
• Repetitive or prolonged neutropenia or thrombocytopenia during previous therapy.
• Concurrent malignancy other than malignancies under study. Subjects who have had another malignancy and have been disease free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible.
• Prior radiation therapy.
• Myelosuppressive chemotherapy within the past 28 days or has not recovered from the myelosuppressive effects of recent chemotherapy.
• Use of an investigational agent, including an investigational anti-cancer agent, immunotherapy, biological therapy, or hormonal therapy within 28 days prior to the first dose of study treatment.
• Prior major surgery or trauma within 28 days prior to the first dose of study treatment and/or presence of any non-healing wound, fracture, or ulcer.
• History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis.
• Inability to swallow a capsule or clinically significant gastrointestinal abnormalities including, but not limited to:
• Malabsorption syndrome
• Major resection of the stomach or small bowel that could affect the absorption of study treatment
• Active peptic ulcer disease
• Inflammatory bowel disease
• Ulcerative colitis, or other gastrointestinal conditions with increased risk of perforation
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to beginning study treatment.
• Unresolved bowel obstruction or diarrhea ≥ Grade 1
• Known intraluminal metastatic lesion(s) with risk of bleeding
• Known endobronchial lesions or involvement of large pulmonary vessels by tumor.
• Presence of uncontrolled infection.
• Prolongation of corrected QT interval > 480 milliseconds.
• History of any one or more of the following cardiovascular conditions within the past 6 months:
• Cardiac angioplasty or stenting
• Myocardial infarction
• Unstable angina
• Coronary artery bypass graft

Where it is running

• The West Clinic — Memphis, Tennessee, United States

Full record on ClinicalTrials.gov

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